[Emergo, UL] Changes to Good Manufacturing Practice Regulations in Mexico: SaMD, UDI and More

Our second post on the new draft of the NOM for Medical Device Good Manufacturing Practices (GMP), PROY-NOM-241-SSA1-2024, discusses relevant updates concerning the restructure of content and key changes over the requirements for manufacturers, conditioners, and distributors of medical devices in Mexico.

 

Reorganization of PROY-NOM-241-SSA1-2024

This new draft contains several structural changes that simplify the organization.

Section 5, which described medical device classification, has been deleted. The Mexican Pharmacopoeia is the primary regulatory instrument for medical device classification.

The current version of the standard includes several paragraphs outlining the supporting features that a quality management system (QMS) should have under section 6.1.4. The draft simplifies this by turning section 5.1.4 into a list of five QMS continuous improvement activities that the organization’s upper management should oversee.

 

PROY-NOM-241-SSA1-2024 Consolidates Information About Retention Samples

NOM-241-SSA1-2021 introduced the concept of retention samples, which are defined as a certain quantity of raw materials or finished product to perform two complete analyses (except for sterility testing). Requirements and treatment of retention samples are outlined in several sections in the current standard, but the draft now collects most of it under section 11.4.  This specifies that these are applicable to formulated medical devices, IVDs, combined and biologically produced medical devices. Nonetheless, the ultimate intent and purpose of these and the requirement to keep samples per each manufactured lot remains unclear.

 

 

Mexico COFEPRIS Revises Draft of GMP Standard (emergobyul.com)

Changes to Good Manufacturing Practice Regulations in Mexico: SaMD, UDI and More

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